Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

IMAGER FLUSH CATHETERS

K-Number: K884354 · 1989-04-21

ApplicantMedi-Tech, Inc.
Decision Date1989-04-21
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IMAGER FLUSH CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Tech, Inc.. It received FDA 510(k) clearance on 1989-04-21 under 510(k) number K884354. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGER FLUSH CATHETERS?

IMAGER FLUSH CATHETERS is a medical device that received FDA 510(k) clearance on 1989-04-21. The listed applicant is Medi-Tech, Inc.. The 510(k) number is K884354.

When did IMAGER FLUSH CATHETERS receive FDA 510(k) clearance?

IMAGER FLUSH CATHETERS received FDA 510(k) clearance on 1989-04-21, under 510(k) number K884354.

Who is the listed applicant for IMAGER FLUSH CATHETERS?

The FDA 510(k) record lists Medi-Tech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMAGER FLUSH CATHETERS?

The FDA product code for IMAGER FLUSH CATHETERS is DQO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medi-Tech, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K954457MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETERK952345MEDI-TECH PLATFORM GUIDE CATHETERK952056IMMUNOASSAY DRUGS OF ABUSE CONTROLSK945289DOA - IMMUNOASSAY CUT-OFF CALIBRATORK942551THERAPEUTIC DRUG MONITORING CONTROL, ASSAYEDK943290BILIRUBIN PLUS/PEDIATRIC CONTROLS

View all 36 devices →

Related Devices (Code: DQO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261455Arterial Pressure Monitoring Set/TraySpectrum VascularK252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602NBioptimal International Pte. , Ltd.K254278Arterial Pressure Monitoring Set/TraySpectrum VascularK250751DualView CatheterTerumo CorporationK242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLCK242420pNOVUS 21 MicrocatheterPhenox, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑